ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 8.4.1: Creation of records

What does 8.4.1 require?

Records that show this document is being met shall be created and kept by the laboratory in readable form, in any medium, made at the time of every activity bearing on examination quality.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) · 1 control

  • 1283 Maintain a test record system that captures positive specimen identification, the date and time of receipt, the condition and disposition of unacceptable specimens, and the records and dates of all testing including who performed each test, and retain patient testing records including instrument printouts

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.

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